Two Allergy Medications Linked to Rare Severe Itch Cases
Published: June 16, 2025
June 16, 2025
The U.S. Food and Drug Administration (FDA) is warning of a rare side effect involving two oral allergy medications. Some people who stopped long-term use of the oral allergy medicines cetirizine or levocetirizine reported rare but severe itching.
Cetirizine is marketed as the brand name Zyrtec®. Levocetirizine is marketed as Xyzal®. They are available in both prescription and over-the-counter forms.
The reported cases are involving the popular allergy medications are extremely rare. FDA reported 209 cases of severe itch in five years linked to cetirizine and levocetirizine. (Millions of people use these medications to treat seasonal allergies every year.) Patients experienced widespread itch symptoms, sometimes across the whole body. They did not experience severe itching prior to taking the medications.
The itching, called pruritus, occurs within a few days of stopping the medications. It has occurred in people who have used the medicines daily for a few months to years. The itching may occur without any signs of a rash.
FDA has revised each of the medications’ prescribing information. It includes a warning about the rare but severe itching risk. FDA has requested the drug manufacturers insert the same warning on their over-the-counter version.
What people with allergies need to know
Cetirizine and levocetirizine are antihistamines (allergy pills). They block or reduce histamine that the body releases in response to an allergen. Both are approved to treat seasonal allergies and year-round allergies (including perennial allergic rhinitis). They are also approved to treat chronic hives.
When deciding whether to take these medications long-term, discuss the benefits vs. risks with your healthcare provider. It may be best to taper off use of the medications instead of stopping abruptly.
People who develop severe itching after stopping daily use of the medicines should contact their doctor for medical help. Treatment may include taking the medicine again and then gradually tapering off its use.
What is pruritus?
Pruritus is a condition that involves an itchy sensation on the skin that triggers the urge to scratch. It is usually caused by skin conditions such as eczema, chronic idiopathic urticaria or psoriasis. It can also be part of an allergic reaction. Pruritus symptoms may also include dry, scaly skin or redness on the skin. People who experience itching from pruritus say it is often worse at night. Chronic or severe pruritus may indicate an underlying medical issue.
Reviewed by:
Purvi Parikh, MD, FACAAI, is an adult and pediatric allergist and immunologist at Allergy and Asthma Associates of Murray Hill in New York City. She is on faculty as Clinical Assistant Professor in both departments of Medicine and Pediatrics at New York University School of Medicine.
